Evidence map›Paper›PMID 37625235›Full record

Trial reportGynecologic oncology2023

Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer.

Sandro Pignata, Michael Bookman, Jalid Sehouli, Austin Miller, Richard T Penson, Cagatay Taskiran, Charles Anderson, Sakari Hietanen, Tashanna Myers, Radoslaw Madry and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03038100 (A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03038100 phase3completednot on this map

A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2022Enrolled1,301ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal NeoplasmsArmsPaclitaxel, Carboplatin, Atezolizumab, Bevacizumab, Atezolizumab Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 10 countries.

Sandro PignataMulticentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G Pascale, Napoli, Italy. Electronic address: s.pignata@istitutotumori.na.it.
Michael BookmanGynecologic Oncology Group Foundation (GOG-F) and Kaiser Permanente Northern California, San Francisco, CA, USA. Electronic address: Michael.A.Bookman@kp.org.
Jalid SehouliArbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe (AGO Study Group), Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (North-Eastern German Society of Gynaecologic Oncology; NOGGO) and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin, Germany. Electronic address: jalid.sehouli@charite.de.
Austin MillerGOG-F and Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: Austin.Miller@RoswellPark.org.
Richard T PensonMassachusetts General Hospital, Boston, MA, USA. Electronic address: Penson.Richard@mgh.harvard.edu.
Cagatay TaskiranTurkish Society of Gynecologic Oncology (TRSGO) and Koç University School of Medicine, Istanbul, Turkey; Vehbi Koç Vakfı American Hospital, Istanbul, Turkey. Electronic address: cagataytaskiran@yahoo.com.
Charles AndersonGOG-F and Willamette Valley Cancer Institute, Eugene, OR, USA. Electronic address: Charles.Anderson@USONCOLOGY.COM.
Sakari HietanenNordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark and Turku University Hospital, Turku, Finland. Electronic address: Sakari.Hietanen@tyks.fi.
Tashanna MyersGOG-F and Baystate Medical Center, Springfield, MA, USA. Electronic address: tashanna.myersmd@baystatehealth.org.
Radoslaw MadryDepartment of Oncology, Poznań University of Medical Sciences, Poznań, Poland. Electronic address: radoslaw.madry@skpp.edu.pl.
Lyndsay WillmottGOG-F and Arizona Oncology Associates, PC, Phoenix, AZ, USA. Electronic address: lyndsay.willmott@arizonaccc.com.
Alain LortholaryGroupe d'Investigateurs National des Etudes des Cancers Ovariens et du sein (GINECO) and Hôpital Privé du Confluent, Nantes, France. Electronic address: ALAIN.LORTHOLARY@groupeconfluent.fr.
Jessica Thomes-PepinGOG-F and Minnesota Oncology, Maplewood, MN, USA. Electronic address: Jessica.ThomesPepin@usoncology.com.
Carol AghajanianGOG-F and Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: aghajanc@MSKCC.ORG.
Carolyn McCourtDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Washington University School of Medicine, Saint Louis, MO, USA. Electronic address: cmccourt@wustl.edu.
Ashley StuckeyThe Warren Alpert Medical School, Brown University, Providence, RI, USA. Electronic address: AStuckey@Wihri.org.
Xiaohua WuDepartment of Gynecological Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wu.xh@fudan.edu.cn.
Shin NishioDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan. Electronic address: shinshin@med.kurume-u.ac.jp.
Larry J CopelandDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Comprehensive Cancer Center/James Cancer Hospital, Columbus, OH, USA. Electronic address: Larry.Copeland@osumc.edu.
Yvette HeGlobal Data Operations, Functional Service Provider, Parexel International, Chengdu, China. Electronic address: yvette.he@businesspartner.roche.com.
Luciana MolineroOncology Biomarker Development, Genentech, Inc., South San Francisco, CA, USA. Electronic address: molinero.luciana@gene.com.
Sheetal PatelPatient-Centered Outcomes Research, Genentech, Inc., South San Francisco, CA, USA. Electronic address: patel.sheetal@gene.com.
Yvonne G LinProduct Development Oncology, Genentech, Inc., South San Francisco, CA, USA. Electronic address: lin-liu.yvonne@gene.com.
Victor K KhorProduct Development Oncology, Genentech, Inc., South San Francisco, CA, USA. Electronic address: khor.victor@gene.com.
Kathleen N MooreGOG-F and Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA; Sarah Cannon Research Institute, Nashville, TN, USA. Electronic address: Kathleen-Moore@ouhsc.edu.
Gene Therapy Laboratory · FRArizona Oncology · USBaystate Medical Center · USBrown University · USFudan University Shanghai Cancer Center · CNGynecologic Oncology Group · USHôpital privé du Confluent · FRIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITKoç University · TRKurume University · JPMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USNordic Society of Gynecologic Oncology · DKNord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie · DEPAREXEL International (United Kingdom) · GBPatient-Centered Outcomes Research Institute · USPoznan University of Medical Sciences · PLRoswell Park Comprehensive Cancer Center · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USUniversity of Oklahoma Health Sciences Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveTo determine the impact on overall survival (OS) and patient-reported outcomes (PROs) of combining atezolizumab with standard therapy for newly diagnosed stage III/IV ovarian cancer.

methodsThe placebo-controlled double-blind randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial (NCT03038100) assigned eligible patients to 3-weekly atezolizumab 1200 mg or placebo for 22 cycles with platinum-based chemotherapy and bevacizumab. Coprimary endpoints were progression-free survival (already reported) and OS in the PD-L1-positive and intent-to-treat (ITT) populations, tested hierarchically. Prespecified PRO analyses focused on disease-related abdominal pain and bloating symptoms (European Organisation for Research and Treatment of Cancer QLQ-OV28), functioning, and health-related quality of life (HRQoL) (QLQ-C30).

resultsAfter 38 months' median follow-up, the OS hazard ratio in the PD-L1-positive population was 0.83 (95% CI, 0.66-1.06; p = 0.13); median OS was not estimable with atezolizumab versus 49.2 months with placebo. The hazard ratio for OS in the ITT population was 0.92 (95% CI, 0.78-1.09; median 50.5 versus 46.6 months, respectively). At week 9, similar proportions of patients in both arms of the neoadjuvant cohort showed ≥10-point improvement from baseline in abdominal pain and bloating, functioning, and HRQoL. In the primary surgery cohort, similar proportions of patients in each arm had improved, stable, or worsened physical and role function and HRQoL from baseline over time. Neither cohort showed differences between arms in treatment-related symptoms or overall side-effect bother.

conclusionsIncorporation of atezolizumab into standard therapy for newly diagnosed ovarian cancer does not significantly improve efficacy or impose additional treatment burden for patients. CLINICALTRIALS: gov registration: NCT03038100.

Indexed as

Ovarian NeoplasmsQuality of LifeAbdominal PainAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarcinoma, Ovarian EpithelialFemaleHumansPatient Reported Outcome MeasuresAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 AntigenImmune checkpoint blockadeOvarian cancerOverall survivalPatient-reported outcomesPD-L1

Identifiers

PMID37625235
PMCPMC10986425
OpenAlexW4386112430

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.